Head of Quality Control

6 hours ago


Holly Springs NC USA, United States FUJIFILM Corporation Full time
Overview

Fujifilm Diosynth Biotechnologies is seeking a highly skilled and experienced Senior Director of Quality Control to lead our Quality Control Laboratories at our state-of-the-art facility in Holly Springs, North Carolina. As a key member of our site leadership team, you will be responsible for developing and implementing the Quality Control strategy, building and leading a high-performing QC team, and ensuring compliance with cGMP and regulatory requirements.

Key Responsibilities
  • Develop and implement the Quality Control strategy and roadmap for the Holly Springs site, aligned with the global Quality Strategy.
  • Build, develop, and lead a high-performing QC team, providing clear priorities, feedback, and career development opportunities.
  • Create and transition the QC department to a new state-of-the-art laboratory.
  • Lead the growth and expansion of the QC team, including regional accountabilities for intra-company testing.
  • Provide strategic decision-making, prioritizing deliverables to meet site and compliance objectives.
  • Oversee all QC operations, including In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, and Environmental and Utility Monitoring.
  • Support and participate in client visits, audits, and regulatory agency inspections.
  • Ensure budgets, timelines, schedules, and performance requirements are established and met.
  • Assure all areas of responsibility conform to cGMP and other appropriate regulatory requirements.
Requirements
  • Bachelor's Degree in Chemistry, Biochemistry, Microbiology, or related field with 15+ years of experience, or Master of Science (M.Sc.) in a related discipline with 13+ years of experience, or PhD in Science with 10+ years of experience.
  • At least 7 years of leadership/management experience.
  • Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategy.
  • Experience leading client site visits, audits, and regulatory inspections.


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